Optimal one-stage design and analysis for efficacy expansion in Phase I oncology trials.

Wu, Cai; Liu, Fang; Zhou, Heng; Wu, Xiaoqiang; Chen, Cong

Wu, Cai; Liu, Fang; Zhou, Heng; Wu, Xiaoqiang; Chen, Cong.

Affiliation

Wu C; Biostatistics and Research Decision Sciences, Merck & Co., Inc., Kenilworth, NJ, USA.
Liu F; Biostatistics and Research Decision Sciences, Merck & Co., Inc., Kenilworth, NJ, USA.
Zhou H; Biostatistics and Research Decision Sciences, Merck & Co., Inc., Kenilworth, NJ, USA.
Wu X; Department of Statistics, Florida State University, Tallahassee, FL, USA.
Chen C; Biostatistics and Research Decision Sciences, Merck & Co., Inc., Kenilworth, NJ, USA.

Clin Trials ; 18(6): 673-680, 2021 12.

Article in En | MEDLINE | ID: mdl-34693772

Subject(s)

Neoplasms; Research Design; Humans; Medical Oncology; Neoplasms/drug therapy; Prospective Studies; Sample Size

Key words

Basket trial; efficacy screening; heterogeneity; immuno-oncology; master protocol; optimal design

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Full text: 1 Database: MEDLINE Main subject: Research Design / Neoplasms Type of study: Observational_studies / Prognostic_studies Limits: Humans Language: En Journal: Clin Trials Journal subject: MEDICINA / TERAPEUTICA Year: 2021 Type: Article Affiliation country: United States

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